ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF A SIMULTANEOUS DETERMINATION OF CITICOLINE AND PIRACETAM AT SINGLE WAVELENGTH
Abstract
A simple, selective, rapid, precise, accurate, sensitive and robust RP-HPLC method has been developed and validated for the determination of citicoline and piracetam in tablet dosage form. The method was carried out on a column- Phenomenex Gemini C18 (250×4.6mm,5µ) with a mobile phase consisting of 0.02M potassium dihydrogen phosphate buffer and acetonitrile in the ratio 95:5 ( pH adjusted to 6.9 with 0.1%v/v triethylamine). Detection was carried out at 220 nm and the flow rate is 1.0 ml/min. The retention time of citicoline and piracetam was found to be 2.3 and 2.8 respectively. Results of the analysis were validated statistically and by recovery studies; accuracy (99.3-102.9%) and reproducibility was found to be satisfactory. The developed method was validated in terms of accuracy, precision, linearity, and limit of detection, limit of quantification, ruggnedness and robustness studies. The proposed method can be successfully used to determine the drug content of marketed formulation.
Key words: RP-HPLC; Citicoline; Piracetam; Simultaneous determination; Method Validation
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